Serious prostate diseases are experienced by one in six men over the age of 40, including prostate cancer. Additionally, BPH, a condition wherein the prostate is enlarged causing discomfort, frequent urination, and urgency of urination, is developed by more than half of all men over age 60. Prostate disease, especially prostate cancer, can be detected by higher than normal prostate specific antigen (PSA) levels. Normal PSA levels are defined as less than about 4 nanograms per milliliter (ng/mL). PSA is a protein produced by the prostate gland and is normally present in small amounts in men. However, with the presence of prostate disease, the level of PSA can be elevated beyond or above normal levels.
Treatments for prostate associated diseases include medications, surgery, chemotherapy, and/or radiation therapy. Often these treatments can prolong life, but can cause significant toxicities, reduction of enjoyment of life, significant side effects, a decrease in the immune system activity, and may not be curative.
A large retrospective analysis of men with PSA-only recurrence of prostate cancer after radical prostatectomy found that a Gleason Grade of 7 or higher and a PSA doubling time of 12 months or less defined a population of men for whom early androgen deprivation therapy (ADT) was associated with delayed development of clinical metastasis. For those at lower risk, in the absence of documented benefit for early ADT, a non-toxic, non-hormonal intervention would be preferable. Accordingly, there is a demand for a natural prostate health composition which is effective and less toxic than androgen ablation therapy, chemotherapy, and/or radiation therapy.